MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 5/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX212T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the gav 2.0 (#fx212t) didn't work properly as it is faulty.At pre-implantation check no flow through valve.Then after flushing flow but at measure 15cm h2o as opposed to 5cm h2o.The valve was not implanted and a differnet was used and functioned normally.No patient harm was reported.The sample will be returned for evaluation to the manufacturer.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on going.Should relevant additional information: investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
The sample was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no significant deformations or damage of the valve was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of blockage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the valve operates within the accepted tolerance in the horizontal but not in the vertical position.An accelerated outflow of gav 2.0 in the vertical position could be determined.Internal inspection : after dismantling of the valve, deposits were found.Summary of the investigation results: firstly, the testing dry products is only of limited value.Dry residues of test liquid or organic material can falsify the test results.Based on the test results, it could be determined an accelerated outflow at the valve in the vertical position.The visible deposits in the valve may have led to the change in flow rate.The reason for the return could not be confirmed in our investigations.It is impossible to determine how the mentioned malfunction occurred during the test before use.The technical test of manufacturer to results may differ from the test results in the clinic.However, the conditions in the laboratory of the manufacturer are optimally adapted to the examinations.The situation on the patient and in the clinic can be very specific and is difficult to reproduce in the laboratory.

• Brand Name: GAV 2.0 VALVE 5/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 18829375
• Report Number: 3004721439-2024-00059
• Device Sequence Number: 15400258
• Product Code: JXG
• UDI-Device Identifier: 04041906500023
• UDI-Public: 4041906500023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX212T
• Device Catalogue Number: FX212T
• Device Lot Number: 20057152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown